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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator For Hemoglobin And Hematocrit Measurement
510(k) Number K873832
Device Name REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801
Applicant
In Vitro Diagnostics, Inc.
415 Howe Ave.
Shelton,  CT  06484
Applicant Contact JAY MININBERG
Correspondent
In Vitro Diagnostics, Inc.
415 Howe Ave.
Shelton,  CT  06484
Correspondent Contact JAY MININBERG
Regulation Number864.8165
Classification Product Code
KRZ  
Date Received09/21/1987
Decision Date 11/23/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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